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Health Canada Medical devices

Sonicaid Freedom Wireless Fetal Monitoring System

Issued October 26, 2022
Issue
Huntleigh has received a report from a user regarding the potential for inappropriate clinical diagnosis and action due to the incorrect setup of the RF channels. In the particular case in question, both units had been inadvertently set to the same RF channel and were placed in close proximity to each other, leading to the second unit displaying the FHR from the first unit. Recall start date: October 19, 2022
Hazard description
Performance
Product
Product name
Sonicaid Freedom Wireless Fetal Monitoring System
Reference
ID
RA-72082